NCT04523740

Paracetamol Discontinuation in the Elderly After Long-term Consumption

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To investigate if long-term treatment of paracetamol can be discontinued without no worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.

Detailed description

Aim: To investigate if long-term treatment of paracetamol can be discontinued without worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more. Trial design: Patients are randomized to either arm 1: standard care (paracetamol continuation) or arm 2: experimental treatment (placebo). The investigation is double-blinded. Patients are screened and recruited from Department of respiratory medicine at Copenhagen University Hospital Bispebjerg. Patients with a daily consumption of 3 grams or more of prescribed paracetamol and who comply with the other eligibility criteria will be invited to participate in the trial and asked for written, informed consent. If given we collect data regarding the patient's medications, any medication changes during the intervention and followup, frailty (FRAIL Scale), self-reported history of falls, recent admissions, self-reported health-related quality of life (EQ-5D-5L), level of function tested by hand grib strength and sitting-rising test, and death. Data is collected at baseline and after 2 weeks when ending treatment intervention, and a 26 week follow-up.

Conditions

• Pain, Chronic
• Pain, Medication
• Pain, Discontinuation

Interventions

Type	Name	Description
DRUG	Placebo	Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks
DRUG	Paracetamol	Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-08-24
• Last updated: 2020-08-25

Locations

1 site across 1 country: Denmark